Clinical Evaluation Specialist - Temporary Contract until end of December 2026 - 50% to 100%

Clinical Evaluation Specialist - Temporary Contract until end of December 2026 - 50% to 100%
Reconnue et incontournable depuis plus de 40 ans, Multi Personnel est une agence spécialisée dans la mise à disposition de personnel administratif et de cadres, temporaire et fixe, dans de nombreux secteurs économiques, tels que la banque, sociétés financières, multinationales, ONG, PME et institutions locales.
Nous souhaitons recruter un/e Clinical Evaluation Specialist – Temporary Contract until end of December 2026 – 50% to 100%
Mission :
Lead and ensure the quality of the full Clinical Evaluation package (LSPR, CEP, CER):
Oversee external authors and validate their work, ensuring all evidence sources (IFUs, risk files, PMS data, testing, labeling, complaints, vigilance, literature) are correctly interpreted, updated in the relevant sections, and fully aligned across the Clinical Evaluation. This is the core and most time‑critical part of the role.
Onboard and guide external CER vendors:
Provide initial training and ongoing support so vendors understand Company expectations, evidence structure, and how to work efficiently with the high volume of supporting documents.
Deliver submission‑ready clinical documentation and improve processes:
Prepare PMCF Plans/Reports, SSCPs, and clinical sections of Technical Documentation, while refining templates and workflows to increase consistency and support RA during notified body interactions.
Profil
Over 5 years of experience in clinical evaluation writing, ideally in the orthopedic field, focusing on spine surgery.
Qualification in a clinical or medical field, with strong expertise in Clinical Evaluation documentation
Advanced knowledge of the EU 2017/745 MDR regulatory framework
Fluent in French and English mandatory
Ton interlocuteur/trice :
Ton contact pour ce poste est Leila. Avec plus de 15 ans d’expérience dans le domaine du recrutement, il/elle saura t’accompagner, te conseiller et t’apporter la réponse à toutes tes questions concernant le poste. Nous ne répondrons qu’aux candidatures dont le profil correspond au descriptif demandé. jpid2c9fd07ob jpit0834ob jpiy26ob